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Last Updated: April 22, 2024

GLAXOSMITHKLINE Company Profile


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Drugs and US Patents for GLAXOSMITHKLINE

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Glaxosmithkline JESDUVROQ daprodustat TABLET;ORAL 216951-003 Feb 1, 2023 RX Yes No 11,649,217 ⤷  Try a Trial Y ⤷  Try a Trial
Glaxosmithkline ZEJULA niraparib tosylate TABLET;ORAL 214876-001 Apr 26, 2023 RX Yes No 8,143,241 ⤷  Try a Trial ⤷  Try a Trial
Glaxosmithkline JESDUVROQ daprodustat TABLET;ORAL 216951-004 Feb 1, 2023 RX Yes No 11,649,217 ⤷  Try a Trial Y ⤷  Try a Trial
Glaxosmithkline THORAZINE chlorpromazine hydrochloride TABLET;ORAL 009149-013 Approved Prior to Jan 1, 1982 DISCN No No ⤷  Try a Trial ⤷  Try a Trial
Glaxosmithkline TRELEGY ELLIPTA fluticasone furoate; umeclidinium bromide; vilanterol trifenatate POWDER;INHALATION 209482-001 Sep 18, 2017 RX Yes Yes 8,183,257 ⤷  Try a Trial ⤷  Try a Trial
Glaxosmithkline Llc REQUIP ropinirole hydrochloride TABLET;ORAL 020658-001 Sep 19, 1997 DISCN Yes No ⤷  Try a Trial ⤷  Try a Trial
Glaxosmithkline Cons THRIVE nicotine polacrilex GUM, CHEWING;BUCCAL 077656-001 Jun 19, 2007 DISCN No No ⤷  Try a Trial ⤷  Try a Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

Expired US Patents for GLAXOSMITHKLINE

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Glaxosmithkline ARNUITY ELLIPTA fluticasone furoate POWDER;INHALATION 205625-001 Aug 20, 2014 5,873,360 ⤷  Try a Trial
Glaxosmithkline NIX permethrin LOTION;TOPICAL 019435-001 Mar 31, 1986 4,024,163 ⤷  Try a Trial
Glaxosmithkline MALARONE PEDIATRIC atovaquone; proguanil hydrochloride TABLET;ORAL 021078-002 Jul 14, 2000 5,998,449*PED ⤷  Try a Trial
Glaxosmithkline WELLBUTRIN bupropion hydrochloride TABLET;ORAL 018644-003 Dec 30, 1985 3,885,046 ⤷  Try a Trial
Glaxosmithkline Llc REQUIP XL ropinirole hydrochloride TABLET, EXTENDED RELEASE;ORAL 022008-002 Jun 13, 2008 5,422,123 ⤷  Try a Trial
Glaxosmithkline ZANTAC 150 ranitidine hydrochloride CAPSULE;ORAL 020095-001 Mar 8, 1994 5,028,432*PED ⤷  Try a Trial
Glaxosmithkline Llc LANOXICAPS digoxin CAPSULE;ORAL 018118-004 Sep 24, 1984 4,088,750 ⤷  Try a Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration
Paragraph IV (Patent) Challenges for GLAXOSMITHKLINE drugs
Drugname Dosage Strength Tradename Submissiondate
➤ Subscribe Extended-release Tablets 2 mg ➤ Subscribe 2008-10-14
➤ Subscribe Extended-release Tablets 3 mg ➤ Subscribe 2009-01-08
➤ Subscribe Injection 6 mg/0.5 mL, 0.5 mL vials ➤ Subscribe 2004-10-25
➤ Subscribe Tablets 0.25 mg, 0.5 mg, 1 mg and 2 mg ➤ Subscribe 2004-12-22
➤ Subscribe Tablets 100 mg ➤ Subscribe 2007-10-31
➤ Subscribe Tablets 62.5 mg/25 mg ➤ Subscribe 2010-09-14
➤ Subscribe Extended-release Capsules 225 mg and 425 mg ➤ Subscribe 2006-10-11
➤ Subscribe Extended-release Tablets 25 mg, 50 mg, 100 mg, 200 mg, 250 mg, and 300 mg ➤ Subscribe 2014-02-12
➤ Subscribe Extended-release Tablets 8 mg ➤ Subscribe 2008-11-03
➤ Subscribe Extended-release Tablets 12 mg ➤ Subscribe 2009-02-05
➤ Subscribe Extended-release Tablets 6 mg ➤ Subscribe 2009-07-22
➤ Subscribe Tablets 150 mg ➤ Subscribe 2007-10-30
➤ Subscribe Orally Disintegrating Tablets 25 mg, 50 mg, 100 mg, and 200 mg ➤ Subscribe 2009-12-21
➤ Subscribe Injection 6 mg/0.5 mL, 0.5 mL (prefilled syringes) ➤ Subscribe 2006-05-09
➤ Subscribe Tablets 3 mg, 4 mg and 5 mg ➤ Subscribe 2005-02-04
➤ Subscribe Tablets 250 mg/100 mg ➤ Subscribe 2009-04-03
➤ Subscribe Extended-release Capsules 325 mg ➤ Subscribe 2006-11-07
➤ Subscribe Oral Suspension 750 mg/5 mL ➤ Subscribe 2009-10-20
➤ Subscribe Extended-release Tablets 4 mg ➤ Subscribe 2008-10-31
➤ Subscribe Extended-release Tablets 3 mg ➤ Subscribe 2009-01-08

Supplementary Protection Certificates for GLAXOSMITHKLINE Drugs

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1633724 PA2015016 Lithuania ⤷  Try a Trial PRODUCT NAME: OLAPARIBUM; REGISTRATION NO/DATE: EU/1/14/959 20141216
1740177 58/2014 Austria ⤷  Try a Trial PRODUCT NAME: UMECLIDINIUMBROMID; REGISTRATION NO/DATE: EU/1/14/922 (MITTEILUNG) 20140430
2506844 2018C/022 Belgium ⤷  Try a Trial PRODUCT NAME: EEN FARMACEUTISCH COMBINATIEPRODUCT DAT EEN FARMACEUTISCH AANVAARDBAAR ZOUT VAN UMECLIDINIUM (BV. UMECLIDINIUMBROMIDE), VILANTEROL OF EEN FARMACEUTISCH AANVAARDBAAR ZOUT DAARVAN (BV. VILANTEROLTRIFENATAAT) EN FLUTICASONEFUROAAT OMVAT; AUTHORISATION NUMBER AND DATE: EU/1/17/1236 20171117
2316456 300918 Netherlands ⤷  Try a Trial PRODUCT NAME: NALTREXON OF EEN FARMACEUTISCH AANVAARDBAAR ZOUT DAARVAN, IN HET BIJZONDER NALTREXONHYDROCHLORIDE, EN BUPROPION OF EEN FARMACEUTISCH AANVAARDBAAR ZOUT DAARVAN, IN HET BIJZONDER BUPROPIONHYDROCHLORIDE; REGISTRATION NO/DATE: EU/1/14/988 20150330
0659181 2001C/014 Belgium ⤷  Try a Trial PRODUCT NAME: AMPRENAVIR; NATL. REGISTRATION NO/DATE: EU/1/00/148/001 20001020; FIRST REGISTRATION: CH 55072 01 19990512
1110543 08C0004 France ⤷  Try a Trial PRODUCT NAME: DESLORATADINE; PSEUDOEPHEDRINE SULFATE; REGISTRATION NO/DATE: EU/1/07/399/001 20070730
1740177 122014000096 Germany ⤷  Try a Trial PRODUCT NAME: UMECLIDINIUMBROMID; REGISTRATION NO/DATE: EU/1/14/922/001-003 20140428
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description
Similar Applicant Names
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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.